DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-402]
Schedules of Controlled Substances: Temporary Placement of Three Synthetic
Cannabinoids into Schedule I
Under the CSA, every controlled substance is classified into one of five schedules
based upon its potential for abuse, its currently accepted medical use in treatment in the
United States, and the degree of dependence the drug or other substance may cause. 21
U.S.C. 812. The initial schedules of controlled substances established by Congress are
found at 21 U.S.C. 812(c), and the current list of all scheduled substances is published at
21 CFR part 1308. 21 U.S.C. 812(a).
Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney General with the
authority to temporarily place a substance into schedule I of the CSA for two years
without regard to the requirements of 21 U.S.C. 811(b) if he finds that such action is
necessary to avoid imminent hazard to the public safety. 21 U.S.C. 811(h). In addition,
if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1), the Attorney
General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).
Where the necessary findings are made, a substance may be temporarily scheduled if
it is not listed in any other schedule under section 202 of the CSA, 21 U.S.C. 812, or if
there is no exemption or approval in effect for the substance under section 505 of the
Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1); 21
CFR part 1308. The Attorney General has delegated scheduling authority under 21
U.S.C. 811 to the Administrator of the DEA, 28 CFR 0.100, who in turn has redelegated
that authority to the Deputy Administrator of the DEA, 28 CFR part 0, appendix to
subpart R.
Background
Section 201(h)(4) of the CSA (21 U.S.C. 811(h)(4)) requires the Deputy
Administrator to notify the Secretary of the Department of Health and Human Services
(HHS) of his intention to temporarily place a substance into schedule I of the CSA.1 The
Deputy Administrator transmitted notice of his intent to place AB-CHMINACA, ABPINACA, and THJ-2201 in schedule I on a temporary basis to the Assistant Secretary by
letter dated September 17, 2014. The Assistant Secretary responded to this notice by
letter dated September 30, 2014, and advised that based on a review by the Food and
Drug Administration (FDA), there are currently no investigational new drug applications
or approved new drug applications for AB-CHMINACA, AB-PINACA, or THJ-2201.
The Assistant Secretary also stated that HHS has no objection to the temporary placement
of AB-CHMINACA, AB-PINACA, and THJ-2201 into schedule I of the CSA. ABCHMINACA, AB-PINACA, and THJ-2201 are not currently listed in any schedule under
the CSA, a condition of 21 U.S.C. 811(h)(1).
To find that placing a substance temporarily into schedule I of the CSA is necessary
to avoid an imminent hazard to the public safety, the Deputy Administrator is required to
consider three of the eight factors set forth in 21 U.S.C. 811(c): the substances history
and current pattern of abuse; the scope, duration and significance of abuse; and what, if
any, risk there is to the public health. 21 U.S.C. 811(h)(3). Consideration of these
factors includes actual abuse, diversion from legitimate channels, and clandestine
importation, manufacture, or distribution. 21 U.S.C. 811(h)(3).
A substance meeting the statutory requirements for temporary scheduling may only
be placed in schedule I. 21 U.S.C. 811(h)(1). Substances in schedule I are those that
1
Because the Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the
authority to make domestic drug scheduling recommendations, for purposes of this notice of intent, all
subsequent references to Secretary have been replaced with Assistant Secretary. As set forth in a
memorandum of understanding entered into by the HHS, the Food and Drug Administration (FDA), and the
National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS in carrying out
the Assistant Secretarys scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 FR
9518, Mar. 8, 1985.
have a high potential for abuse, no currently accepted medical use in treatment in the
United States, and a lack of accepted safety for use under medical supervision. 21 U.S.C.
812(b)(1). Available data and information for AB-CHMINACA, AB-PINACA, and
THJ-2201 indicate that these three synthetic cannabinoids (SCs) have a high potential for
abuse, no currently accepted medical use in treatment in the United States, and a lack of
accepted safety for use under medical supervision.
Synthetic Cannabinoids
SCs are chemicals synthesized in laboratories and mimic the biological effects of
delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in marijuana.
These chemicals, such as CP-47,497 and cannabicyclohexanol (both designed in the
1980s and currently controlled pursuant to the Food and Drug Administration Safety and
Innovation Act (FDASIA), Pub. L. 112-144), were initially used as research tools to
investigate the biological mechanisms in the cannabinoid system and to develop novel
therapies for various clinical conditions. Other SCs including JWH-018, JWH-073, and
JWH-200 (all permanently controlled pursuant to FDASIA) were synthesized in the mid1990s and studied to advance the understanding of drug-receptor interactions in the
cannabinoid system.
SCs were marketed in several European countries as herbal incense before the
initial encounter in the United States by U.S. Customs and Border Protection (CBP) in
November 2008. In 2009, their use began increasing in the United States with law
enforcement encounters describing SCs laced on plant material and being abused for their
psychoactive properties. In addition, forensic analyses by the DEA and other Federal,
State, and local laboratories have identified multiple variations in both the type and
amount of SC applied to the plant material.
As observed by the DEA and CBP, SCs originate from foreign sources, including
China and other countries in Southeast Asia. Bulk substances are smuggled via common
carrier into the United States and find their way to clandestine designer drug product
manufacturing operations located in residential neighborhoods, garages, warehouses, and
other similar destinations throughout the country. The powder form of SCs are typically
dissolved in solvents (e.g., acetone) before being applied to a green plant material or
dissolved in a propellant intended for use in e-cigarette devices.
SCs are marketed under hundreds of different brand names, including Spice, K2,
Blaze, Red X Dawn, Paradise, Demon, Black Magic, Spike, Mr. Nice
Guy, Ninja, Zohai, Yucatan, Fire, Crazy Clown, Mojo, Black Mamba,
Black Voodoo, Scooby Snax, Bizzaro, and many others. In addition, various new
generations of SCs reflect the same or similar product labels while yielding a higher
intensity and longer lasting highs, but with the user still being deprived of knowledge as
to exactly what is contained inside the packaging.
The drug products laced with SCs are often sold under the guise of herbal incense,
potpourri, etc., using various product names and routinely labeled not for human
consumption. Additionally, these products are marketed as a legal high or legal
alternative to marijuana and are readily available over the Internet, in head shops, or
sold in convenience stores. There is an incorrect assumption that these products are safe
and further, that mislabeling these products as not for human consumption is a legal
defense to criminal prosecution.
These substances have no accepted medical use in the United States and have been
reported to produce adverse health effects in humans while having a negative effect on
communities. Acute and chronic abuse of SCs in general have been linked to adverse
health effects including signs of addiction and withdrawal, numerous reports of
emergency room admissions resulting from their abuse, overall toxicity, and death.
AB-CHMINACA, AB-PINACA, and THJ-2201 are SCs that have pharmacological
effects similar to the schedule I hallucinogen THC and other temporarily and
permanently controlled schedule I substances. With no approved medical use and limited
safety or toxicological information, AB-CHMINACA, AB-PINACA, and THJ-2201 have
emerged on the illicit drug market and are being abused for their psychoactive properties.
The DEAs analysis is available in its entirety under Supporting and Related Material
of the public docket for this action at www.regulations.gov under docket number DEA402.
Factor 4. History and Current Pattern of Abuse
SCs have been developed over the last 30 years as tools for investigating the
cannabinoid system. Synthetic cannabinoids intended for illicit use were first reported in
the United States in a November 2008 encounter, where a shipment of "Spice" was seized
and analyzed by CBP in Dayton, Ohio. At approximately the same time, in December
2008, JWH-018 and cannabicyclohexanol (CP-47,497 C8 homologue) were identified by
German forensic laboratories. Since the initial identification of JWH-018 (November
2008), many other SCs have been found applied on plant material and encountered as
drug products. The popularity of these cannabinoids and their associated products
appears to have increased since January 2010 in the United States based on seizure
exhibits and public health and media reports.
Numerous SCs have been identified as product adulterants, and law enforcement has
seized bulk amounts of these substances. The first SCs identified as being abused include
JWH-018, JWH-073, JWH-200, CP-47,497, and CP-47,497 C8 homologue, followed
shortly thereafter by new generations of SCs including drugs such as UR-144, XLR11,
AKB48, PB-22, 5F-PB-22, AB-FUBINACA, ADB-PINACA, and numerous other SCs
varying only by slight modifications to their chemical structure. JWH-018, JWH-073,
JWH-200, CP-47,497, and CP-47,497 C8 homologue were temporarily scheduled on
March 1, 2011 (76 FR 11075), and later permanently placed in schedule I by Section
1152 of FDASIA on July 9, 2012. Section 1152 of FDASIA amended the CSA by
placing cannabimimetic agents and 26 specific substances (including 15 synthetic
cannabinoids, 2 synthetic cathinones, and 9 synthetic phenethylamines of the 2C- series)
into schedule I. UR-144, XLR11, and AKB48 were temporarily scheduled on May 16,
2013 (78 FR 28735). PB-22, 5F-PB-22, AB-FUBINACA, and ADB-PINACA were
temporarily scheduled on February 10, 2014 (79 FR 7577).
Another generation of SCs including AB-CHMINACA, AB-PINACA, and THJ-2201
has recently been encountered. AB-CHMINACA, AB-PINACA, and THJ-2201 are not
included among the 15 SCs that are specifically named under FDASIA, and do not fall
under the legal definition of cannabimimetic agents as provided under FDASIA. These
substances and products laced with these substances are commonly marketed under the
guise of being a legal high with a disclaimer of not for human consumption. As
detailed in reports, law enforcement and public health officials are encountering the
abuse of these substances.
A major concern as reiterated by public health officials and medical professionals
remains the targeting and direct marketing of SCs and SC-containing products to
adolescents and youth. This is supported by law enforcement encounters and reports
from emergency rooms (see Factor 6 of Background Information and Evaluation of
Three Factor Analysis (Factors 4, 5, and 6) for Temporary Scheduling); however, all
age groups have been reported by media as abusing these substances and related
products. Recently, law enforcement has been encountering new variations of SCs in
liquid form. The liquids contain one or more SCs, including AB-CHMINACA and ABPINACA. Users have been identified applying the liquid to hookahs (an instrument for
vaporizing and smoking a given material whereby the smoke or vapor passes through a
water basin prior to inhalation), vaporizers (also known as vaping or an e-cigarette,
which allows the user to administer a liquid to be aerosolized and then inhaled), and
hookah pens (a type of vaporizer, often much smaller and intended for increased
discretion while smoking). Similar to conventional illicit manufacturing of SC products,
liquid preparations of these substances do not adhere to any manufacturing standards with
regard to dosage, the substance(s) included, purity, or contamination. It is important to
note that following manufacturing principles or standards would not eliminate the
adverse effects observed with SC products and SCs would still be considered a threat to
public safety.
System to Retrieve Information from Drug Evidence (STRIDE) is a database of drug exhibits sent to DEA
laboratories for analysis. Exhibits from the database are from the DEA, other Federal agencies, and law
enforcement agencies.
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National Forensic Laboratory Information System (NFLIS) is a national drug forensic laboratory
reporting system that systematically collects results from drug chemistry analyses conducted by state and
local forensic laboratories in the United States.
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aware of any currently accepted medical uses for these SCs in the United States. A
substance meeting the statutory requirements for temporary scheduling, 21 U.S.C.
811(h)(1), may only be placed in schedule I. Substances in schedule I are those that have
a high potential for abuse, no currently accepted medical use in treatment in the United
States, and a lack of accepted safety for use under medical supervision. Available data
and information for AB-CHMINACA, AB-PINACA, and THJ-2201 indicate that these
three SCs have a high potential for abuse, no currently accepted medical use in treatment
in the United States, and a lack of accepted safety for use under medical supervision. As
required by section 201(h)(4) of the CSA, 21 U.S.C. 811(h)(4), the Deputy
Administrator, through a letter dated September 17, 2014, notified the Assistant Secretary
of the DEAs intention to temporarily place these three SCs in schedule I.
Conclusion
This notice of intent initiates an expedited temporary scheduling action and provides
the 30-day notice pursuant to section 201(h) of the CSA, 21 U.S.C. 811(h). In
accordance with the provisions of section 201(h) of the CSA, 21 U.S.C. 811(h), the
Deputy Administrator considered available data and information, herein set forth the
grounds for his determination that it is necessary to temporarily schedule three SCs, N-(1amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide
(AB-CHMINACA), N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3carboxamide (AB-PINACA) and [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1yl)methanone (THJ-2201) in schedule I of the CSA, and finds that placement of these
SCs into schedule I of the CSA is necessary to avoid an imminent hazard to the public
safety.
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Regulatory Matters
Section 201(h) of the CSA, 21 U.S.C. 811(h), provides for an expedited temporary
scheduling action where such action is necessary to avoid an imminent hazard to the
public safety. As provided in this subsection, the Attorney General may, by order,
schedule a substance in schedule I on a temporary basis. Such an order may not be issued
before the expiration of 30 days from (1) the publication of a notice in the Federal
Register of the intention to issue such order and the grounds upon which such order is to
be issued, and (2) the date that notice of the proposed temporary scheduling order is
transmitted to the Assistant Secretary. 21 U.S.C. 811(h)(1).
In as much as section 201(h) of the CSA directs that temporary scheduling actions be
issued by order and sets forth the procedures by which such orders are to be issued, the
DEA believes that the notice and comment requirements of section 553 of the
Administrative Procedure Act (APA), 5 U.S.C. 553, do not apply to this notice of intent.
In the alternative, even assuming that this notice of intent might be subject to section 553
of the APA, the Deputy Administrator finds that there is good cause to forgo the notice
and comment requirements of section 553, as any further delays in the process for
issuance of temporary scheduling orders would be impracticable and contrary to the
public interest in view of the manifest urgency to avoid an imminent hazard to the public
safety.
Although the DEA believes this notice of intent to issue a temporary scheduling order
is not subject to the notice and comment requirements of section 553 of the APA, the
DEA notes that in accordance with 21 U.S.C. 811(h)(4), the Deputy Administrator will
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take into consideration any comments submitted by the Assistant Secretary with regard to
the proposed temporary scheduling order.
Further, the DEA believes that this temporary scheduling action is not a rule as
defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the
Regulatory Flexibility Act. The requirements for the preparation of an initial regulatory
flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, the DEA is not
required by section 553 of the APA or any other law to publish a general notice of
proposed rulemaking.
Additionally, this action is not a significant regulatory action as defined by Executive
Order 12866 (Regulatory Planning and Review), section 3(f), and, accordingly, this
action has not been reviewed by the Office of Management and Budget.
This action will not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in accordance with
Executive Order 13132 (Federalism) it is determined that this action does not have
sufficient federalism implications to warrant the preparation of a Federalism Assessment.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control, Reporting and
recordkeeping requirements.
For the reasons set out above, the DEA proposes to amend 21 CFR part 1308 as
follows:
PART 1308SCHEDULES OF CONTROLLED SUBSTANCES
1. The authority citation for part 1308 continues to read as follows:
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(h) *
(29) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3carboxamide, its optical, positional, and geometric isomers, salts and salts of isomers
7031 (Other names: AB-CHMINACA)
(30) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide, its
optical, positional, and geometric isomers, salts and salts of isomers 7023
(Other names: AB-PINACA)
(31) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone, its optical,
positional, and geometric isomers, salts and salts of isomers 7024 (Other names: THJ2201)
*
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2014-29651 Filed 12/18/2014 at 8:45 am; Publication Date: 12/19/2014]
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